Lead - WP2 (Clinical Trial)

Michael Ramharter

WP2: Clinical Trial is led by Michael Ramharter (BNITM/Germany) and co-led by Ghyslain Mombo-Ngoma (CERMEL/Gabon)

WP2 activities include the preparation phase and the monitoring of the implementation of the mono-centre preparatory pilot-study project in Gabon (Study I), of the randomized placebo-controlled main multi-centre clinical trial conducted in Benin, Gabon, Ghana, and Mali (Study II), and of the clinical part of the multi-centre pharmacokinetic study (Study III). This includes the development of clinical documents and SOPs. WP2 will supervise the harmonization of each clinical site and will train the local staff in GCP and GCLP. WP2 is responsible for the adverse events reporting system, will interact with WP1 for the management of severe adverse event cases, will interact with WP3 and WP5 for dealing with the sample and data collection, respectively, and with WP6 for the harmonization and capacity development of the trial sites.